Ultibro Breezhaler capsules for inhalation with powdergramm 50 .mu.g + 110 xg kompl.s 30pcs inhaler.

 Bronchodilators – nicotinic acetylcholine receptor blocker m

Active substance:
Glycopyrronium bromide, Indacaterol

Manufacturer

Novartis Pharma Stein AG, Switzerland

Prescribing

Adults are prescribed by a doctor

Composition

Excipients:

lactose monohydrate – 24.9 mg,

magnesium stearate – 0.037 mg.

Capsules Composition:

Valium – 45.59 mg,

Water – 2.7 mg,

Carrageenan – 0.42 mg

sodium chloride – 0.18 mg,

colorant sunset yellow (E110) -. 0.12 mg

The composition of the ink :

shellac, a dye iron oxide black, propylene glycol, sodium hydroxide.

Indications

Asthma, low learning ability, bronchospasm

– maintenance treatment of bronchial disorders of conduction in patients with chronic obstructive pulmonary disease.

Contraindications

– increased sensitivity to glycopyrronium bromide or any other components forming part of the formulation;

– child and adolescence to 18 years;

– simultaneous with inhaled drugs containing other m-holinoblokatory;

– galactose intolerance, lactase deficiency or glucose-galactose malabsorption (formulation contains lactose).

Precautions

Closure glaucoma, diseases accompanied by urinary retention, renal failure, severe (GFR below 30 ml / min / 1.73 m2), including end-stage renal disease requiring hemodialysis (Sibri® Brizhaler® medication should be used only if the expected advantage exceeds the potential risk); unstable coronary artery disease, myocardial infarction, cardiac arrhythmia, lengthening the interval QTc (QT corrected > 0.44 s).

Side effects

The safety profile of the drug Sibri® Brizhaler® characterized by symptoms associated with the m-anticholinergic action, including dry mouth (2.2%), while other effects on the gastrointestinal tract and symptoms were infrequent urination delay.

Adverse drug reactions associated with local tolerability included throat irritation, nasopharyngitis, rhinitis and sinusitis. At recommended dosages Sibri® Brizhaler® drug has no effect on blood pressure and heart rate.

Safety and tolerability Sibri® Brizhaler® was studied when applied at 1353 COPD patients at the recommended dose of 50 mg 1 time / day. Of these, 842 patients were treated for at least 26 weeks and 351 – at least 52 weeks.

Determining the incidence of adverse drug reactions: very often (≥1 / 10); often (≥1 / 100, < 1/10); infrequently (≥1 / 1000, < 1/100); rare (≥1 / 10,000, 1/1000); very rare (< 1/10, 000).

Infectious and parasitic diseases: often – nasopharyngitis; rarely – rhinitis, cystitis.

From a metabolism: rarely – hyperglycemia.

On the part of the mind: often – insomnia.

From the nervous system: common – headache; rarely – hypoesthesia.

Cardio-vascular system: rarely – atrial fibrillation, palpitations.

The respiratory system, thorax and mediastinum: infrequently – congestion in the sinuses, productive cough, throat irritation, nasal bleeding.

From the digestive system: often – dry mouth, gastroenteritis; infrequently – indigestion, dental caries.

Skin and subcutaneous tissue disorders: rare – skin rash.

From the musculoskeletal system: rare – pain in the limbs, the pain of the skeletal muscles of the chest.

From the urinary system: often – urinary tract infection; rarely – dysuria, urinary retention.

General disorders: rarely – fatigue, asthenia.

In a clinical study lasting 12 months, the following additional adverse events were identified that met more frequently when using the drug Sibri® Brizhaler® compared to placebo: nasopharyngitis (9.0% vs. 5.6%), vomiting (1.3% vs. 0.7%), muscle pain ( 1.1% vs. 0.7%), pain in the neck (1.3% vs. 0.7%), diabetes (0.8% vs. 0%).

Adverse drug reactions received during post marketing studies and reported in the literature: as the data reported in voluntarily from a population of uncertain size, to determine their frequency is not possible (the frequency is unknown) – angioedema.

In elderly patients over 75 years old the incidence of urinary tract infections and headache when applied Sibri®Brizhaler® drug was higher than in the placebo group (3.0% vs. 1.5% and 2.3% vs 0%, respectively) .

If any of the above side effects are aggravated or incurred any other side effects, the patient should inform the doctor.

How to accept, acceptance rate and dosage

Each pack of the drug contains Sibri® Brizhaler®:

– one inhalation device – Brizhaler®;

– blisters with capsules with powder for inhalation.

Capsules with powder for inhalation should not be taken internally!

Brizhaler® inhalation device, which is in the package is approved for use only in conjunction with the capsules of the drug.

For inhalation capsules in the package is only an inhalation device Brizhaler®.

Do not use the drug capsules with any other inhalation device and, in turn, do not use Brizhaler® for inhalation of other drugs.

After 30 days of use Brizhaler® should be discarded.

How to use an inhaler

1. Remove the cover.

2. Open Brizhaler®. To open the inhaler should firmly take his base and tilt the mouthpiece.

3. Prepare capsule: separate one blister from the blister package by tearing it along the perforations; take one blister and remove the protection film to release the capsule; not extrude through the capsule protective film.

4. Remove the capsule: the capsule in the blister should be stored and removed only immediately prior to use; wipe hands dry and remove the capsule from the blister. Do not swallow the capsule.

5. Insert capsule in Brizhaler®: put the capsule in the capsule chamber; never put a capsule directly into the mouthpiece.

6. Close Brizhaler®: seal the inhaler; when it closes to the end, you will hear a “click”.

7. Pierce capsule: Brizhaler® be retained in an upright position so that the mouthpiece faces upward; simultaneously press until the end of the two buttons; capsule when piercing sounds “click”; no key is pressed for puncturing the capsule 1 once more.

8. Fully release inhaler Brizhaler® buttons on both sides.

9. Exhale: Before you insert the mouthpiece into your mouth, you should make a full exhalation; I never blow into the mouthpiece.

10. Inhale medication: Brizhaler® hold in your hand so that the buttons were on the left and the right (but not the top and bottom); invest Brizhaler® inhaler mouthpiece in your mouth and tightly compressed lips around it; make a quick, uniform, maximally deep breath. Do not press the buttons of the lancing device.

11. At inhalation through the inhaler, the patient should hear the rattling sound characteristic generated by the rotation of the capsule in the chamber and the powder spray. This may appear sweet taste of the drug.

If a rattling noise is absent, it may indicate that the capsule is stuck in the inhaler chamber. In this case, open the inhaler and carefully release the capsule by tapping the base of the device. To release the capsule, no key is pressed to pierce the capsule. steps 9 and 10 should be repeated if necessary.

12. Hold your breath if inhaled characteristic sound appears, you should hold your breath as long as possible (so as not to feel discomfort), and at the same time pull the mouthpiece out of his mouth. After that exhale. Open Brizhaler® and see whether remains of the capsule powder. If the powder left in the capsule, close Brizhaler® and repeat steps 9-12. In most cases, the capsule emptied either 1 or 2 inhalations. Some patients in a short time after the inhalation is marked cough. If the cough is not present, then the patient should not have to worry. If the powder in the capsule is left, then the patient has received the full dose of the drug.

13. Remove the empty capsule: after daily dosage adopted Sibri®Brizhaler® preparation follows rejecting mouthpiece, remove the empty capsule, tapping the inhaler, and discard it. Close the mouthpiece of the inhaler Brizhaler®i Brizhaler® close the lid. Do not store the capsules in the inhaler Brizhaler®.

Do not swallow capsules with powder for inhalation.

Use only Brizhaler® in the package.

The capsules should be stored in the blister and removing immediately before use.

Never put the capsule into the mouthpiece of the inhaler Brizhaler®. Do not press the lancing device more than 1 times.

Never blow into the mouthpiece of the inhaler Brizhaler®.

Always pierce the capsule before inhalation.

Do not wash Brizhaler®. Keep it dry. Do not disassemble Brizhaler®.

Starting a new product package, for inhalation capsules should always use new Brizhaler® in the package.

Do not store the capsules in the inhaler Brizhaler®.

Always keep the blisters with capsules and Brizhaler® in a dry place.

In very rare cases, a small amount of the contents of the capsules can get into your mouth when inhaling or swallowing; it does not matter.

If the capsule has been pierced more than once, increasing the risk of breakage.

How to clean Brizhaler®

Brizhaler® should be cleaned 1 time per week. Wipe the outside and inside of the mouthpiece with a clean dry cloth. Never use water for cleaning the inhaler Brizhaler®. Keep it dry.

Active substance

Glycopyrronium bromide, Indacaterol

Interaction

Concomitant use of glycopyrronium bromide and indacaterol inhalation agonist beta2-adrenergic receptors, does not affect the pharmacokinetics of both drugs.

In clinical studies in healthy volunteers, cimetidine, organic cation transporter inhibitor affecting the renal clearance glycopyrronium bromide, increased overall exposure (AUC) glycopyrronium bromide in 22% and reduced renal clearance by 23%.

Based on these figures, it is not intended clinically significant interaction with simultaneous application of the drug Sibri® Brizhaler® cimetidine or other inhibitors conveyors cations.

In vitro studies showed that the drug Sibri® Brizhaler® probably does not affect the metabolism of other drugs.

Inhibition of metabolism or induction of glycopyrronium bromide does not lead to significant changes in systemic exposure of the drug.

Special conditions

Sibri® Brizhaler® drug is not recommended for the relief of acute bronchospasm episodes.

Hypersensitivity reactions

cases of hypersensitivity reactions have been reported immediately after the drug type Sibri® Brizhaler®. If there are signs that the development of allergic reactions, including angioedema (including difficulty breathing or swallowing, swelling of the tongue, lips and face), urticaria or rash, the drug must cancel and choose alternative therapy.

The paradoxical bronchospasm

As in other cases, inhalation therapy using the product Sibri®Brizhaler® can lead to the paradoxical bronchospasm that may be life-threatening. In the case of paradoxical bronchospasm, the use of the drug Sibri® Brizhaler® should be discontinued immediately and alternative therapy used.

M-anticholinergic effect

Like other m-anticholinergic drugs Sibri®Brizhaler® drug should be used with caution in patients with narrow-angle glaucoma or urinary retention.

Patients should be informed of the signs and symptoms of an acute attack of angle-closure glaucoma and the need to stop using the product Sibri® Brizhaler® and immediately inform your doctor in case of any of these signs or symptoms.

Renal failure, severe

Patients with impaired renal function (GFR of less than 30 ml / min / 1.73 m2), including patients with end-stage disease requiring hemodialysis requires careful monitoring for possible development of adverse drug reactions.

Sibri® Brizhaler® drug for the maintenance treatment of patients with COPD.

Due to the fact that in the general population of COPD patients predominate over the age of 40 years, when using the drug in patients under 40 years is required spirometric confirmation of the diagnosis of COPD.

Effects on ability to drive vehicles and management mechanisms

Preparation Sibri® Brizhaler® does not adversely affect the ability to control pas vehicles mechanisms.

Overdose

No data on drug overdose Sibri® Brizhaler®.

Patients with COPD, regular inhalational administration formulation Sibri®Brizhaler® a total dose of 100 and 200 mg 1 time per day for 28 days was well tolerated. Acute intoxication if accidentally swallowed capsule preparation Sibri® Brizhaler® unlikely due to the low glycopyrronium bromide bioavailability upon oral administration (about 5%).

Cmax in plasma and total systemic exposure after i / v injection of 150 micrograms glycopyrronium bromide (equivalent to 120 micrograms glycopyrronium) from healthy volunteers were approximately 50 and 6 times higher, respectively, than the Cmax in plasma and total systemic exposure in an equilibrium state, achieved with the use of the drug Sibri® Brizhaler® inhalation at recommended doses (50 .mu.g 1 time / day). Signs of overdose is not detected.